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QC summary table

Quality Check Question Y/N
Error checking
  1 Are there any alphabetical or non-numeric values anywhere for any cell? Yes
  2 Are there any empty cells in the dataset? ✔ No
  3 Are there any impossible values in the dataset? ?
Dates and times
  4 Does the dosing event date occur before the date of the first positive concentration value in each subject? ✔ Yes
  5 Are all dates and times in consistent format? No
Covariates
  6 Do any time-invariant covariates change over time? ?
  7 Do any time-variable covariates don’t change over time? ?
  8 Do histograms of the covariates show any multimodalities? ?
  9 Do categorical variables have the appropriate number of levels? ?
Dependent variables
  10 Are all the dependent variable (DV) values of one type? ?
  11 Are there any DV outliers? ?
NONMEM specific
  12 Are dosing records appropriately flagged in the EVID column (e.g., EVID=1)? ?
  13 Are non-dosing events appropriately flagged in the EVID column (e.g., EVID=2)? ?
  14 Are missing DV values appropriately handled? ?

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Dataset overview

Number of columns (total): 16

Number of rows (total): 1030

Number of unique IDs: 64

Number of observations per IDs: mean 16.09 , median 14 , min 14 , max 26

Error checking

❕ There are alphabetical or non-numeric values in the dataset: in the columns DVID, SEX, STUDY, VCOR_GENOTYPE .

There are no empty cells in the dataset.

There are no NAs in the dataset.

For the impossible values check the Covariates and Dependent variable sections.

Dates and times

Columns specified by user: TIME

❕ Multiple time format detected: #, #.#

No date column provided

Covariates

Covariates specified by user: WT, CLCR, AGE, SEX, STUDY, ECOG_STATUS, VCOR_GENOTYPE

Covariates identified to be time-invariant: WT, CLCR, AGE, SEX, STUDY, ECOG_STATUS, VCOR_GENOTYPE

Covariates identified to be time-varying: ECOG_STATUS

There are no covariates with empty cells in the dataset.

Time-varying covariates

Here are spaghetti plots for the covariates that were identified identified to be time-varying.


Categorial covariates

Explore this section to address Quality Check questions 3, 9

Check boxes if everything is ok

Covariates specified as categorical: SEX , STUDY , ECOG_STATUS , VCOR_GENOTYPE

IDs with value
Values per ID
SEX N fraction N fraction
female 10 0.16 20.20 1
male 54 0.84 15.33 1
IDs with value
Values per ID
STUDY N fraction N fraction
STD_1 32 0.5 16.09 1
STD_2 32 0.5 16.09 1
IDs with value
Values per ID
ECOG_STATUS N fraction N fraction
0 19 0.30 13.47 0.87
1 21 0.33 13.38 0.82
2 31 0.48 15.90 0.97
IDs with value
Values per ID
VCOR_GENOTYPE N fraction N fraction
AA 21 0.33 16.00 1
AG 26 0.41 15.92 1
GG 17 0.27 16.47 1

Numerical covariates

Explore this section to address Quality Check questions 3, 8

Check boxes if everything is ok

Covariates specified as continuous: WT , CLCR , AGE

■ - possible outliers

Dependent variable

Explore this section to address Quality Check questions 10, 11

Check boxes if everything is ok

Dependent variable statistics (by provided DV-grouping indicators):

DVID STUDY Mean Median Min Max SD Q0.25 Q0.75
cp STD_1 6.41 6.10 0.00 17.60 3.82 3.20 8.90
cp STD_2 6.75 6.75 -3.33 22.00 5.02 3.04 9.80
pca STD_1 37.50 28.00 9.00 100.00 26.06 20.00 42.00
pca STD_2 37.72 28.60 4.34 107.82 25.90 20.68 42.61


DV distribution
- possible outliers

Spaghetti Plot of DV vs TIME by IDs

NONMEM-specific

NONMEM-specific columns specified by user: DVID , EVID , AMT , CMT , MDV

Explore this section to additionally address Quality Check questions 12, 13

IDs with value
Values per ID
DVID N fraction N fraction
1 64 1 8.84 0.54
2 64 1 7.25 0.46
IDs with value
Values per ID
EVID N fraction N fraction
0 64 1 15.09 0.94
1 64 1 1.00 0.06
IDs with value
Values per ID
MDV N fraction N fraction
0 64 1 15.09 0.94
1 64 1 1.00 0.06
IDs with value
Values per ID
CMT N fraction N fraction
1 64 1.0 1.00 0.06
2 32 0.5 15.09 0.94
4 32 0.5 15.09 0.94
AMT information
Distribution

For non-zero AMT values:

Mean Median Min Max SD Q0.25 Q0.75
152.5 176.5 60 200 49.7 108.75 200

Summary

Groupped summary:

IDs with value
Values per ID
AMT N fraction N fraction
AMT = 0 or “.” 64 1 15.09 0.94
AMT > 0 64 1 1.00 0.06

Detailed summary:

IDs with value
Values per ID
AMT N fraction N fraction
0.0 64 1.00 15.09 0.94
60.0 1 0.02 1.00 0.05
75.0 2 0.03 1.00 0.04
85.0 1 0.02 1.00 0.05
87.0 2 0.03 1.00 0.07
88.5 1 0.02 1.00 0.07
90.0 1 0.02 1.00 0.06
93.0 2 0.03 1.00 0.07
95.5 1 0.02 1.00 0.07
100.0 3 0.05 1.00 0.06
105.0 2 0.03 1.00 0.07
110.0 1 0.02 1.00 0.07
112.0 2 0.03 1.00 0.07
113.0 3 0.05 1.00 0.06
115.0 1 0.02 1.00 0.07
117.0 1 0.02 1.00 0.07
120.0 4 0.06 1.00 0.07
123.0 1 0.02 1.00 0.05
125.0 1 0.02 1.00 0.07
135.0 1 0.02 1.00 0.05
153.0 1 0.02 1.00 0.07
200.0 32 0.50 1.00 0.06


EVID = 0 EVID = 1
DVID = 1 7.84 1
DVID = 2 7.25 0
CMT = 1 CMT = 2 CMT = 4
DVID = 1 1 3.92 3.92
DVID = 2 0 3.62 3.62
MDV = 0 MDV = 1
DVID = 1 7.84 1
DVID = 2 7.25 0
CMT = 1 CMT = 2 CMT = 4
EVID = 0 0 7.55 7.55
EVID = 1 1 0.00 0.00
MDV = 0 MDV = 1
EVID = 0 15.09 0
EVID = 1 0.00 1
MDV = 0 MDV = 1
CMT = 1 0.00 1
CMT = 2 7.55 0
CMT = 4 7.55 0

DVID = 1 DVID = 2
AMT = 0 or “.” 502 464
AMT > 0 64 0
EVID = 0 EVID = 1
AMT = 0 or “.” 966 0
AMT > 0 0 64
CMT = 1 CMT = 2 CMT = 4
AMT = 0 or “.” 0 483 483
AMT > 0 64 0 0
MDV = 0 MDV = 1
AMT = 0 or “.” 966 0
AMT > 0 0 64







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